510(k) K801891
K801891 is an FDA 510(k) premarket notification submitted by Wako Pure Chemical Industries, Ltd. for the device "WAKO TRIGLYCERIDE-G TEST". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Wako Pure Chemical Industries, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 1980
- Date Received
- August 8, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Device Class
- Class I
- Regulation Number
- 862.1705
- Review Panel
- CH
- Submission Type